ID

32697

Descripción

Insulin Glargine (Lantus) vs Sulfonylurea (SU) for BETA Cell Function (BETA Study); ODM derived from: https://clinicaltrials.gov/show/NCT00562172

Link

https://clinicaltrials.gov/show/NCT00562172

Palabras clave

Versiones (1)
  1. 12/11/18 12/11/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

12 de noviembre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes Mellitus NCT00562172

Inglés

Eligibility Type 2 Diabetes Mellitus NCT00562172

1 formularios  
Criteria
Descripción

Criteria

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes mellitus patients on metformin monotherapy
Descripción

Diabetes Mellitus, Non-Insulin-Dependent | Metformin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0025598
7% ≤ hba1c ≤ 12%
Descripción

Hemoglobin A1c measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0474680
20 kg/m² ≤bmi ≤ 35 kg/m²
Descripción

Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1305855
diabetes duration: at least 6 months
Descripción

Diabetes Mellitus Disease length

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C0872146
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
type 1 diabetes mellitus patients
Descripción

Diabetes Mellitus, Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011854
clinical evidence of active liver disease, or serum alanine aminotransferase 3 times the upper limit of the normal range
Descripción

Liver diseases | Alanine aminotransferase increased

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0151905
serum creatinine: 1.5 mg/dl for males, 1.4 mg/dl for females
Descripción

Creatinine measurement, serum | Gender

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0079399
acute and chronic metabolic acidosis, including diabetic ketoacidosis
Descripción

Metabolic acidosis | Chronic metabolic acidosis | Diabetic Ketoacidosis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0220981
UMLS CUI [2]
C0740749
UMLS CUI [3]
C0011880
history of alcohol or other substance abuse
Descripción

Substance Use Disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
pregnancy or not using contraceptive in childbearing aged women
Descripción

Pregnancy | Childbearing Potential Contraceptive methods Absent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332197
known hypersensitivity to lantus, su or metformin
Descripción

Hypersensitivity Lantus | Sulfonylurea allergy | Metformin allergy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0876064
UMLS CUI [2]
C0571636
UMLS CUI [3]
C0571648
any disease or condition that in the opinion of the investigator may interfere with completion of the study
Descripción

Disease Interferes with Completion of clinical trial | Condition Interferes with Completion of clinical trial

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2732579
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2732579
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Descripción

Study Subject Participation Status | Considerations Additional

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0518609
UMLS CUI [2,2]
C1524062
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Similar models

Eligibility Type 2 Diabetes Mellitus NCT00562172

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
Diabetes Mellitus, Non-Insulin-Dependent | Metformin
Item
type 2 diabetes mellitus patients on metformin monotherapy
boolean
C0011860 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
Hemoglobin A1c measurement
Item
7% ≤ hba1c ≤ 12%
boolean
C0474680 (UMLS CUI [1])
Body mass index
Item
20 kg/m² ≤bmi ≤ 35 kg/m²
boolean
C1305855 (UMLS CUI [1])
Diabetes Mellitus Disease length
Item
diabetes duration: at least 6 months
boolean
C0011849 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent
Item
type 1 diabetes mellitus patients
boolean
C0011854 (UMLS CUI [1])
Liver diseases | Alanine aminotransferase increased
Item
clinical evidence of active liver disease, or serum alanine aminotransferase 3 times the upper limit of the normal range
boolean
C0023895 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Creatinine measurement, serum | Gender
Item
serum creatinine: 1.5 mg/dl for males, 1.4 mg/dl for females
boolean
C0201976 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Metabolic acidosis | Chronic metabolic acidosis | Diabetic Ketoacidosis
Item
acute and chronic metabolic acidosis, including diabetic ketoacidosis
boolean
C0220981 (UMLS CUI [1])
C0740749 (UMLS CUI [2])
C0011880 (UMLS CUI [3])
Substance Use Disorders
Item
history of alcohol or other substance abuse
boolean
C0038586 (UMLS CUI [1])
Pregnancy | Childbearing Potential Contraceptive methods Absent
Item
pregnancy or not using contraceptive in childbearing aged women
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Hypersensitivity Lantus | Sulfonylurea allergy | Metformin allergy
Item
known hypersensitivity to lantus, su or metformin
boolean
C0020517 (UMLS CUI [1,1])
C0876064 (UMLS CUI [1,2])
C0571636 (UMLS CUI [2])
C0571648 (UMLS CUI [3])
Disease Interferes with Completion of clinical trial | Condition Interferes with Completion of clinical trial
Item
any disease or condition that in the opinion of the investigator may interfere with completion of the study
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
Study Subject Participation Status | Considerations Additional
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])
C0518609 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])
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